Health of Young European Families and Fish Consumption

Overweight Clinical Trial

Official title:

Health of Young European Families and Fish Consumption

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00315770
• Other study ID #: FQS-506359
• Status: Active, not recruiting
• Phase: Phase 1
• Start date: January 2004
• Est. completion date: April 2020

Study information

• Verified date: August 2018
• Source: Landspitali University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a controlled, randomized, intervention trial (CRIT) with 20-40 year old overweight individuals (n = 320) across Europe in order to distinguish between biologically active components of seafood, i.e., seafood proteins and n-3 lipids, regarding their effects on risk factors for metabolic syndrome, bone health, and weight management.

Description:

Subjects were recruited through advertisements from October 2004 until April 2005. Recruitment of 320 subjects (140 from Iceland, 120 from Spain, and 60 from Ireland). The inclusion criteria were body mass index (BMI) 27.5 to 32.5 kg/m2, age 20-40 years, and a waist circumference of equal or more than 94 cm and 80 cm for men and women, respectively. Exclusion criteria were weight change due to weight loss diet within 3 months before the start of the study, use of supplements giving n-3 fatty acids, calcium or vitamin-D during the last three months, drug treatment of diabetes mellitus, hypertension or hyperlipidemia and women's pregnancy or lactation. Each subject was instructed to follow a diet, energy-restricted by 30% from estimated energy expenditure (approximately 600 kcal/day), for 8 consecutive weeks. The subjects were randomly assigned to four diets varying in types of dietary protein and amount of n-3 fatty acids (especially very long chain n-3 fatty acids):

I: no seafood (control, including 6 placebo capsules/day)

II: lean fish (150 g cod x 3/week)

III: fatty fish (150 g salmon x 3/week)

IV: fish-oil capsules (6 capsules/day)

Risk factors for metabolic syndrome, bone health and weight management were analysed at baseline and endpoint.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 320
• Est. completion date: April 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 40 Years

Eligibility

Inclusion Criteria:

• Body mass index (BMI) of 27.5 to 32.5 kg/m2

• Ages 20-40 years

• Waist circumference of equal or more than 94 cm and 80 cm for men and women, respectively

Exclusion Criteria:

• Weight change due to weight loss diet within 3 months before the start of the study

• Use of supplements giving n-3 fatty acids

• Calcium or vitamin D during the last three months

• Drug treatment for diabetes mellitus

• Hypertension or hyperlipidemia

• Women's pregnancy or lactation

Related Conditions & MeSH terms

• Bone Resorption
• Metabolic Syndrome X
• Overweight

Intervention

Procedure:
• weight loss diets for young adults

Locations

Country	Name	City	State
n/a

Sponsors (6)

Lead Sponsor	Collaborator
Landspitali University Hospital	European Commission, The National Research Institute on Agriculture and Fisheries Research, Lisbon, Portugal, University College Cork, University of Iceland, University of Navarra

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Weight loss
Primary	Anthropometry
Secondary	Blood lipid profile (total high-density lipoprotein [HDL]- and low-density lipoprotein (LDL)-cholesterol, triacylglycerol)
Secondary	Fatty acid composition of red blood cells
Secondary	Fasting plasma glucose and fasting insulin
Secondary	C-reactive protein
Secondary	Prostaglandins
Secondary	Interleukins
Secondary	Intercellular adhesion molecules
Secondary	Vascular cell adhesion molecules
Secondary	Antioxidants/pro-oxidants
Secondary	Serum ghrelin
Secondary	Leptin
Secondary	Quantitative insulin-sensitivity check index (QUICKI)
Secondary	Adiponectin
Secondary	Plasminogen activator inhibitor (PAI-1)
Secondary	Cortisol
Secondary	Glutathione (GSH) reductase
Secondary	Malondialdehyde
Secondary	Bone specific alkaline phosphatase
Secondary	Osteocalcin
Secondary	Parathyroid hormone (PTH)
Secondary	25-hydroxyvitamin D3 [25(OH) D3]
Secondary	Creatinine
Secondary	Pyridinoline (Pyr) and deoxypyridinoline (Dpyr)
Secondary	Visual analogue scale for satiety